SOP Amphotericin

SOP: Care of a Patient Receiving Lipid-Complex Amphotericin (Abelcet ®) and Liposomal Amphotericin (AmBisome ®)
Approved by NPC on October 18, 2012
NATIONAL INSTITUTES OF HEALTH
CLINICAL CENTER
NURSING and PATIENT CARE SERVICES
Standard of Practice: Care of a Patient Receiving Lipid-Complex Amphotericin (Abelcet®), and Liposomal Amphotericin (AmBisome ®)
Essential Information
1. Amphotericin B is considered the standard treatment for many severe, invasive fungal infections.1
2
2. Different formulations of amphotericin B products require different dosing and are NOT interchangeable
3. List of Medications:
a. Conventional Amphotericin B Product
Deoxycholate (Fungizone @)
b. Lipid-based Amphotericin B Products
Lipid –Complex Amphotericin B (ABLC Abelcet @, Sigma-tau Pharmaceuticals)
Liposomal Amphotericin B (L-AmB, AmBisome @, Astellas Pharmaceuticals) preferred CC agent
4. All Amphotericin B formulations are compatible only with D5W. The line must be flushed with D5W BEFORE and AFTER each
infusion. 1
5. Lipid-based amphotericin B formulations are associated with less nephrotoxicity than conventional amphotericin B deoxicholate.1,3,4,5
6. Infusion related reactions included: fever, nausea, bronchospasm or cough, and hypoxia was more frequent in patients receiving lipid
based amphotericin B formulations than conventional amphotericin B..1,2,4
7. Amphotericin can be administered as inhalation and/or pulmonary instillation. Note: Medication administration guidelines will be
determined by Licenses Independent Practitioner (LIP).
8. Preparation and dispensing of amphotericin products restricted to the pharmacy.1,5
9. Infusion Duration:
a. Abelcet® is infused at 2.5 mg/kg per hour. If the infusion exceeds 2 hours, agitate the bag every 2 hours.6
b. AmBisome® is infused over 2 hours. This may be decreased to 1 hour if the infusion is well tolerated.7
10. It is recommended that Amphotericin should be separated from blood product administration and cellular therapy by at least 1 hour
and granulocytes infusion by at least 2 hours due to the potential for increased adverse events. Patients receiving granulocyte
transfusions are at increased risk for severe pulmonary reactions. 1,3,7
11. Use caution with concurrent use of antineoplastic agents, as they may enhance the potential for renal toxicity, bronchospasm, and
hypotension. 3,7
12. Patients receiving nephrotoxic agents including: aminoglycosides, NSAIDs, foscarnet, cyclosporine, or tacrolimus are at increased risk
for renal toxicity and should have renal function monitored closely. 1,7
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SOP: Care of a Patient Receiving Lipid-Complex Amphotericin (Abelcet ®) and Liposomal Amphotericin (AmBisome ®)
Approved by NPC on October 18, 2012
13. AmBisome (and other Amphotericin B formulations), can result in a triad of acute infusion related reactions (AIRRs) including: (1)
chest pain, dyspnea, and hypoxia; (2) severe abdominal pain, flank, or leg pain; and (3) flushing and urticaria. These AIRRs occur
within the first 5 minutes of infusion and are managed by interruption of the infusion and administration of medications per LIP
orders. Evidence supports diphenhydramine as first line treatment for AIRRs. 8
14. Intravenous Amphotericin B is an irritant and should be infused via central line when possible due to potential for amphotericin
induced phlebitis and/or thrombophlebitis.1,3 Protect medications from light exposure.
I.
Assessment
4,5
A. Assess patient/family understanding of drug, side effects, and potential reactions.
B. Review lab results: BUN, creatinine, potassium, magnesium, sodium, CBC, and LFT’s.1 Notify LIP if labs are abnormal.
C. Prior to administration of Amphotericin B, assess patients’ risk factors for possible reactions (i.e. recent blood product administration,
concurrent medications ) prior Amphotericin B administration (Fungizone®, Amphotec®, Abelcet®, and AmBisome ®).1,5,9
D. Review and/or obtain LIP orders for premedication and pre-/post-hydration if appropriate.
E. Verify emergency medications are available in the area where patient will receive treatment. 1, 7, 10
F. Assess patients’ temperature, pulse, respiratory rate, and blood pressure as follows:
a. Prior to each Amphotericin B administration
b. During first dose: every 15 minutes x 4, and then every 30 minutes during infusion
c. During subsequent doses: prior to and then every 2 hours until infusion complete
G. Obtain daily weights and/or intake and output as ordered.
II. Interventions
A. Alaris pump guardrails should be utilized when administering Amphotericin B (look under liposomal/lipid).2,9
B. Instruct patient to remain on their patient care unit during medication administration, unless accompanied by a nurse.
C. Verify that the following emergency supplies, medications, and relevant equipment are available on the patient care unit:
1. D5W flush solutions
2. 0.9% sodium chloride solution and administration set
3. oxygen
4. suction
5. vital signs and pulse oximetry monitor
6. anaphylaxis treatment medications
D. Prime IV administration set with D5W
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SOP: Care of a Patient Receiving Lipid-Complex Amphotericin (Abelcet ®) and Liposomal Amphotericin (AmBisome ®)
Approved by NPC on October 18, 2012
E. Administer pre-medications and/or pre- and post-hydration, per LIP order.1
F. In the event of an adverse infusion-related reaction, e.g., fever, rigors, nausea, vomiting, flank pain, leg pain, flushing, hypotension, rash,
or pruritis:
1. Stop infusion and notify LIP
2. Maintain patency of IV access
3. Initiate management strategies, as appropriate
2,10,11
G. In the event of a severe adverse drug reaction, e.g., dyspnea, wheezing, swelling of the tongue or throat
1. Stop the infusion
2. Maintain patency of IV access
3. STAT page LIP, and/or activate Code Blue or Rapid Response Team, as appropriate
4. Initiate emergency management interventions, as appropriate
5.
Initiate oxygen therapy as appropriate
III. Documentation:
A. Document in approved electronic medical record and/or on other approved medical record form:
1. Medication administration
2. Assessment and interventions
3. Adverse reactions and interventions
4. Patient and family/significant other teaching
IV. References:
1.
2.
3.
4.
5.
Drew, R. H., Kauffman, C. A., & Thorner, A. R. (2012). Pharmacology of amphotericin B. Retrieved from:
http://www.uptodate.com/contents/pharmacology-of-amphotericin on 6/13/2012.
Koczmara, C., Richardson, H., Hylard, S., Lee, C. S.Y., Hillebrand, N., (2011) Alert: Mix-ups between conventional and lipid
formulations of amphotericin B can be extremely dangerous Canadian Association of Critical Care Nurses, vol. 22, issue 1, Spring
www.caccn.ca
Amphotericin B. National Library of Medicine HSDB Database. (2006). Retrieved from: http://www.toxnet.nlm.nih.gov
Accessed on 6/20/2012.
Walsh, T., Finberg, R., Arndt, C., Hiemenz, J., Schwartz, C., & Bodensteiner, D. (1999). Liposomal amphotericin B for empirical
therapy in patients with persistent fever and neutropenia. The New England Journal of Medicine, 340(10), 764-771.
Giirois, S. B., Chapuis, F., Decullier, E., & Revol, B. G. (2005). Adverse effects of antifungal therapies in invasive fungal infections:
review and meta-analysis. European Journal of Microbiology and Infectious Disease, 24, 119-130.
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SOP: Care of a Patient Receiving Lipid-Complex Amphotericin (Abelcet ®) and Liposomal Amphotericin (AmBisome ®)
Approved by NPC on October 18, 2012
6.
7.
8.
9.
10.
11.
ABELCET® (Amphotericin B Lipid Complex Injection) Retrieved from:
http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=41233 accessed on 6/24/2012
Astellas Pharma. (2008). AmBisome [package insert]. Retrieved from: http://www.astellas.us/docs/ambisome.pdf. Accessed on
June 24, 2012
Roden, M., Nelson, L.D., Knuden, T. A., Jarosinski, P.F., Starling, J. M., Shiflett, S. E., et. al. (2003). Triad of acute infusion-related
reactions associated with liposomal Amphotericin B: Analysis of clinical and epidemiological characteristics. Clinical Infectious
Diseases, 36, 1213-1220.
Institute for Safe Medication Practices. 2007. Preventing mix-ups between various formulations of amphotericin B. Retrieved from:
http://www.ismp.org/Newsletters/acutecare/articles/20070906_1.asp.
Collazos, J., Martinez, E., Mayo, J., & Ibarra, S. (2001). Pulmonary reactions during treatment with amphotericin B: Review of
published cases and guidelines for management. Clinical Infectious Diseases, 33, 75-82.
Hussein, M.A., Fletcher, R., Long, T.J., Zuccaro, K., Bolwell, B.J., Hoeltge, G.A.(1997) Transfusing platelets 2h after the
completion of amphotericin-B decreases its detrimental effect on transfused platelet recovery and survival. Transfusion Medicine, 8,
43-47
Approved:
//s//
Clare Hastings, R.N., Ph.D., FAAN
Chief, Nursing and Patient Care Services
//s//
Robert DeChristoforo, MS, FASHP, RPh
Chief, Pharmacy Department
Formulated:
4/1997
Implemented:
Reviewed:
10/2001, 7/2009, 10/2012
Revised:
4/2002, 4/2006, 9/2009, 10/2012
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